Supportive CareNCT06722144
Animal-assisted Therapy Improves Cognitive and Emotion in Nursing Home Residents
A study testing Animal-assisted Therapy in people with Supportive Care and Treatment, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
More than 80% of the residents of the investigator's nursing home are dementia, who are often mentally and emotionally unstable. The staff need to spend time helping to eliminate problems. The investigator assume that non-drug intervention measures can be added, such as the Animal-assisted Therapy (AAT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Supportive Care, Treatment, Prevention
- What is being tested?
- Animal-assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Mar 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents of long-term care homes
- No fear or allergy to dogs
- Wheelchair accessible persons
- Able to communicate in Mandarin and Taiwanese
- Agree to sign the subject consent form
Who cannot join
- Non-residents of nursing homes
- Fear and allergy to dogs
- Bedridden and wheelchair users
- Do not agree to sign the subject consent form
- Note: Although many nursing home residents have symptoms of dementia, many have not been diagnosed by a doctor, so dementia and other related diseases cannot be included in the inclusion or exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
More than 80% of the residents of the investigator's nursing home are dementia, who are often mentally and emotionally unstable. The staff need to spend time helping to eliminate problems. The investigator assume that non-drug intervention measures can be added, such as the Animal-assisted Therapy (AAT). The hypothesis for ATT is expected to improve the mental and emotional inappropriate manifestations of dementia, reduce interfering behaviors, improve the quality of life, reduce the use of inappropriate mental drugs, and expect residents to delay the degradation of physiological functions.
Read the detailed description
Nursing homes in the investigator's country accept dementia residents usually. The dementia residents often suffer from mental and emotional problems. Then they used drugs to improve the mental and emotional conditions. There were many studies about non-drug treatments ,such as: gardening, nostalgia, pets, and other interventions were improved for the mental and emotional to dementia residents.Well-trained therapy dogs exhibit the behavior that human patients construe as friendly and welcoming.AAT dogs are also required to possess a calm temperament for accommodating the contact with unfamiliar clients while they serve as a source of comfort. In domestic observational studies, non-pharmaceutical interventions for people with dementia who have activities and the hypothesis for ATT can improve the quality of care for dementia, reduce the use of mentally inappropriate drugs, and delay the degree of degeneration. Recent evidence has shown that nursing institutions with dementia arranged weekly activities with AAT for a period of 6 months. Significant improvement was in social interaction, emotional expression, and behavioral and psychological symptoms.
- Conditions
- Supportive Care, Treatment, Prevention
- Being tested
- Animal-assisted Therapy
- Keywords
- behavioral and psychological symptoms, animal assisted therapy, cognition
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted TherapyBehavioural
Also called pet therapy, the doctor dog
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
| Study group | Role | What they receive |
|---|---|---|
| emotion status | Experimental | Geriatric Depression Scale and Short Form Health Scale(GDS-15) Receives: Behavioral: Animal-assisted Therapy |
| cognition status | Experimental | Short Portable mental state questionnaire(SPMSQ) Receives: Behavioral: Animal-assisted Therapy |
| feeling healthy | Experimental | Brief Symptom Rating Scale(BSRS-5) Receives: Behavioral: Animal-assisted Therapy |
| activities of daily living status | Experimental | Barthel index scale Receives: Behavioral: Animal-assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Portable mental state questionnaire (SPMSQ)
This scale was adopted in this study to assess the participants' cognitive functions.
Measured: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
Secondary outcomes (3)
The Geriatric Depression Scale (GDS-15)
The two scales were adopted in this study to assess the participants' depressive and the participants' emotion state
Measured: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
The Barthel Index
This index was adopted in this study to assess the participants' physical mobility and function.
Measured: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
The Brief Symptom Rating Scale(BSRS-5)
The participants' feeling healthy
Measured: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start14 Mar 2024
- Primary completion10 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nursing home residents were dementia and older.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Su-Jen Wang, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722144
- Sponsor's protocol ID
- 2024-02-014C
- Status last verified
- Dec 2024
- First submitted
- 30 Apr 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have a plan to make individual participant data (IPD) available to other researchers.
Publications
Lai NM, Chang SMW, Ng SS, Tan SL, Chaiyakunapruk N, Stanaway F. Animal-assisted therapy for dementia. Cochrane Database Syst Rev. 2019 Nov 25;2019(11):CD013243. doi: 10.1002/14651858.CD013243.pub2.
PubMed 31763689Chen H, Wang Y, Zhang M, Wang N, Li Y, Liu Y. Effects of animal-assisted therapy on patients with dementia: A systematic review and meta-analysis of randomized controlled trials. Psychiatry Res. 2022 Aug;314:114619. doi: 10.1016/j.psychres.2022.114619. Epub 2022 May 10.
PubMed 35623240
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal-assisted Therapy Improves Cognitive and Emotion in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT06722144
- Acronym / sponsor ID
- 2024-02-014C
- Conditions
- Supportive Care, Treatment, Prevention
- Keywords
- behavioral and psychological symptoms, animal assisted therapy, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 80% of the residents of the investigator's nursing home are dementia, who are often mentally and emotionally unstable. The staff need to spend time helping to eliminate problems. The investigator assume that non-drug intervention measures can be added, such as the Animal-assisted Therapy (AAT). The hypothesis for ATT is expected to improve the mental and emotional inappropriate manifestations of dementia, reduce interfering behaviors, improve the quality of life, reduce the use of inappropriate mental drugs, and expect residents to delay the degradation of physiological functions.
Detailed description
Nursing homes in the investigator's country accept dementia residents usually. The dementia residents often suffer from mental and emotional problems. Then they used drugs to improve the mental and emotional conditions. There were many studies about non-drug treatments ,such as: gardening, nostalgia, pets, and other interventions were improved for the mental and emotional to dementia residents.Well-trained therapy dogs exhibit the behavior that human patients construe as friendly and welcoming.AAT dogs are also required to possess a calm temperament for accommodating the contact with unfamiliar clients while they serve as a source of comfort. In domestic observational studies, non-pharmaceutical interventions for people with dementia who have activities and the hypothesis for ATT can improve the quality of care for dementia, reduce the use of mentally inappropriate drugs, and delay the degree of degeneration. Recent evidence has shown that nursing institutions with dementia arranged weekly activities with AAT for a period of 6 months. Significant improvement was in social interaction, emotional expression, and behavioral and psychological symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Nursing home residents were dementia and older.
| Arm | Type | Receives |
|---|---|---|
| emotion status | Experimental | Behavioral: Animal-assisted TherapyGeriatric Depression Scale and Short Form Health Scale(GDS-15) |
| cognition status | Experimental | Behavioral: Animal-assisted TherapyShort Portable mental state questionnaire(SPMSQ) |
| feeling healthy | Experimental | Behavioral: Animal-assisted TherapyBrief Symptom Rating Scale(BSRS-5) |
| activities of daily living status | Experimental | Behavioral: Animal-assisted TherapyBarthel index scale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Residents of long-term care homes
- No fear or allergy to dogs
- Wheelchair accessible persons
- Able to communicate in Mandarin and Taiwanese
- Agree to sign the subject consent form
Key exclusion criteria (5 listed)
- Non-residents of nursing homes
- Fear and allergy to dogs
- Bedridden and wheelchair users
- Do not agree to sign the subject consent form
- Note: Although many nursing home residents have symptoms of dementia, many have not been diagnosed by a doctor, so dementia and other related diseases cannot be included in the inclusion or exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted TherapyAlso: pet therapy, the doctor dogBy the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs. | Behavioural | activities of daily living status, cognition status, emotion status, feeling healthy |
Primary outcome
The Short Portable mental state questionnaire (SPMSQ)
Time frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
This scale was adopted in this study to assess the participants' cognitive functions.
3 secondary outcomes
The Geriatric Depression Scale (GDS-15)
Time frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
The Barthel Index
Time frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
The Brief Symptom Rating Scale(BSRS-5)
Time frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 31763689Lai NM, Chang SMW, Ng SS, Tan SL, Chaiyakunapruk N, Stanaway F. Animal-assisted therapy for dementia. Cochrane Database Syst Rev. 2019 Nov 25;2019(11):CD013243. doi: 10.1002/14651858.CD013243.pub2.
- Results publication: PubMed 35623240Chen H, Wang Y, Zhang M, Wang N, Li Y, Liu Y. Effects of animal-assisted therapy on patients with dementia: A systematic review and meta-analysis of randomized controlled trials. Psychiatry Res. 2022 Aug;314:114619. doi: 10.1016/j.psychres.2022.114619. Epub 2022 May 10.
- Animal-Assisted Therapy used in psychiatric symptoms and dementia patinets.Link provided by the sponsor.
- Functional Outcomes in a Randomized Controlled Trial of Animal-Assisted Therapy on Middle-Aged and Older Adults with Schizophrenia.Link provided by the sponsor.
- Animal-assisted therapy for dementiaLink provided by the sponsor.
- Effects of animal-assisted therapy on patients with dementia: A systematic review and meta-analysis of randomized controlled trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We don't have a plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-Jen Wang study chair
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted Therapy in people with Supportive Care and Treatment, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short Portable mental state questionnaire (SPMSQ) (time frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.